Trial record 72 of 303 for: Recruiting, Not yet recruiting, Available Studies | Pediatrics
Safety,Efficacy and Pharmacokinetics Evaluation of SCT800 in Previously Treated Paediatric Patients With Severe Haemophilia A.
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|ClinicalTrials.gov Identifier: NCT03947320|
Recruitment Status : Not yet recruiting
First Posted : May 13, 2019
Last Update Posted : May 13, 2019
Information provided by (Responsible Party):
This study is a multicenter phase III uncontrolled open-label trial to evaluate the efficacy,safety and pharmacokinetics of SCT800 in regular prophylaxis and perioperative treatment in patients (＜12 years old) with severe hemophilia A who have been previously treated with coagulation factor VIII(FVIII) . This study includes two phases: the screening period and prophylaxis period.Prophylaxis with 25 - 50 IU/kg of SCT800 shall be administered once every other day or three times per week starting from Visit 1 and prophylaxis with SCT800 shall continue for 24 consecutive weeks.
|Condition or disease||Intervention/treatment||Phase|
|Hemophilia A||Drug: Recombinant Human Coagulation FVIII||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter Phase III Uncontrolled Open-label Trial to Evaluate Safety and Efficacy and Pharmacokinetics of Recombinant Human Coagulation Factor VIII (SCT800) in Previously Treated Paediatric Patients With Severe Haemophilia A.|
|Estimated Study Start Date :||December 20, 2019|
|Estimated Primary Completion Date :||September 20, 2020|
|Estimated Study Completion Date :||September 20, 2020|
Experimental: Recombinant Human Coagulation FVIII
Participant receivedSCT800 for prophylaxis with 25 - 50 IU/kg injection once every other day or three times per week for 6 months.
Drug: Recombinant Human Coagulation FVIII
Participant received SCT800 for prophylaxis with 25 - 50 IU/kg injection once every other day or three times per week for 6 months.
Other Name: SCT800
Primary Outcome Measures :
- Annualized Bleeding Rate [ Time Frame: up to 24 weeks ]Annualized Bleeding Rate（ABR） can be calculated using the following formula: Number of bleeding events in efficacy evaluation period/(number of days in treatment period/365.25)
Secondary Outcome Measures :
- Annualized joint bleeding rate [ Time Frame: up to 24 weeks ]Annualized joint bleeding rate（AJBR） can be calculated using the following formula: Number of joint bleeding events during efficacy evaluation period/(number of days in treatment period/365.25).
- FVIII incremental in-vivo recovery [ Time Frame: Predose within 30 min，15 min±2 min ]Incremental recovery is determined as the peak factor level recorded in the first hour after infusion and is reported as [IU/ml]/[IU/kg]
- Bleeding event treatment efficacy [ Time Frame: up to 24 weeks ]The investigator shall evaluate the hemostatic effect after the treatment of every bleeding event of subjects based on a four-point scale(excellent, good, moderate, not relieved).
- Elimination Half Life [ Time Frame: Predose within 30 min，15 min±2 min、1 hour±5 min，10 hours±30 min，24 hours±1hours and 48 hours±2 hours post-dose ]t1/2; Chromogenic Assay
- Clearance [ Time Frame: Predose within 30 min，15 min±2 min、1 hour±5 min，10 hours±30 min，24 hours±1hours and 48 hours±2 hours post-dose ]CL; Chromogenic Assay
Other Outcome Measures:
- Incidence of FVIII inhibitors [ Time Frame: up tp 24 weeks ]The Nijmegen-Bethesda assay shall be used to monitor the production of FVIII inhibitors during the trial.
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